The Manager Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, cosmetics, combination products and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of responsibility may include supplier qualification and approval, supplier risk management, , supplier change management, , and Approved Supplier List (ASL) governance. This position will also translate strategy into tactical objectives to deliver strategic plans and regulatory updates. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
Responsibilities
- Ensure proper integration and support of quality regulations: drug, biologics, cosmetic, device and/or combination products.
- Lead project teams in planning, preparation, review and approval of quality documentation.
- Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, cosmetic, device and/or combination products including compliance with Corporate policies, processes and procedures.
- Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
- Manage and oversee the interrelated function activities including design control with R&D, Manufacturing Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs.
- Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
- Support new product introduction for pharmaceutical products, medical devices, or combination products. Support design changes to existing medical devices and combination products.
- Interact with internal and external partners for development of best practices in our quality systems and procedures.
- Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
- Oversee the implementation and management of training and education programs for various aspects of quality assurance.